BEUDAMED
    Product Code: MCA FDA class 2 21 CFR 878.3300

    Tape, Surgical, Internal

    General, Plastic Surgery

    The internal surgical tape is a general and plastic surgery implant used internally to approximate or reinforce tissue during surgical procedures, functioning as an internal adhesive or fixation material. It is classified as FDA Class II under 21 CFR 878.3300 within the General and Plastic Surgery specialty, requiring 510(k) premarket clearance. The product code is MCA and it carries an implant flag. Full GMP quality system requirements apply and the device does not sustain life.

    View on FDA
    510(k)s
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    —

    Research product code MCA in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    MCA
    Device Class
    FDA class 2
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K900195 MODIFIED GORE-TEX SURGICAL TAPE

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.